Protocolized vs Discretionary Use of Opioids in Acute Pain
Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Hydromorphone (Drug); IV opioid (Drug)
Phase: Phase 3
Sponsored by: Montefiore Medical Center
Official(s) and/or principal investigator(s):
Andrew K Chang, MD, Principal Investigator, Affiliation: Montefiore Medical Center
We are testing whether patients who received protocolized pain management (1 mg of IV
hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the
patients wants more) will have better pain relief and no more adverse events than patients
receiving discretionary care, in which the patients receives whatever IV opioid the treating
physician wants to give, in whatever dose.
Official title: Protocolized vs Discretionary Use of Opioids in Acute Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Difference in proportion who answer "no" to the question, "Do you want more pain medication?" at 60 minutes.
Difference in proportion of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes
Changes in pain intensity from baseline to other pain assessment times (5, 15, 30, 45 and 60 minutes).
Incidence of adverse events
Minimum age: 21 Years.
Maximum age: 64 Years.
1. Age 21 to 64 years.
2. Pain with onset within 7 days.
3. ED attending physician's judgment that patient's pain warrants use of intravenous
4. Normal mental status.
1. Prior use of methadone.
2. Use of other opioids, tramadol, or heroin in the past seven days.
3. Prior adverse reaction to morphine, hydromorphone, or other opioids.
4. Chronic pain syndrome.
5. Alcohol intoxication.
6. Systolic BP < 90 mm Hg.
7. Use of MAO inhibitors in past 30 days.
8. Weight less than 100 pounds.
9. Baseline room air oxygen saturation less than 95%.
10. C02 measurement greater than 46: In accordance with a number of similar studies that
we have performed, four subsets of patients will have their CO2 measured using a
handheld capnometer prior to enrollment in the study. If the CO2 measurement is
greater than 46, then the patient will be excluded from the study. The 4 subsets are
1. All patients who have a history of COPD
2. All patients who have a history of sleep apnea
3. All patients who report a history of asthma together with greater than a 20
pack-year smoking history
4. All patients reporting less than a 20 pack-year smoking history who are having
an asthma exacerbation
Locations and Contacts
Montefiore Medical Center Emergency Department, Bronx, New York 10467, United States
Starting date: October 2008
Last updated: July 19, 2011